Filamentous Embolization Device With Expansible Elements

• US 20090232869A1
• Filed: 01/29/2009
• Published: 09/17/2009
• Est. Priority Date: 10/04/1999
• Status: Active Grant

• Current Assignee: Brian J. Cox, George R. Greene, Jr., Gregory M. Cruise, Michael Constant, Terrance Tran
• Original Assignee: Brian J. Cox, George R. Greene, Jr., Gregory M. Cruise, Michael Constant, Terrance Tran
• Inventors: Greene, George R. JR., Cox, Brian J., Cruise, Gregory M., Tran, Terrance, Constant, Michael
• Granted Patent: US 8,603,128 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12154 having stretch limiting means
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: B29C 70/74 Moulding material on a relatively small portion of the preformed part, e.g. outsert moulding B29C70/845 takes precedence
• CPC Class Codes: B29L 2031/7542 Catheters

Abstract

An embolization device for occluding a body cavity includes one or more elongated, expansible, hydrophilic embolizing elements non-releasably carried along the length of an elongated filamentous carrier that is preferably made of a very thin, highly flexible filament or microcoil of nickel/titanium alloy. At least one expansile embolizing element is non-releasably attached to the carrier. A first embodiment includes a plurality of embolizing elements fixed to the carrier at spaced-apart intervals along its length. In second, third and fourth embodiments, an elongate, continuous, coaxial embolizing element is non-releasably fixed to the exterior surface of the carrier, extending along a substantial portion of the length of the carrier proximally from a distal tip, and optionally includes a lumenal reservoir for delivery of therapeutic agents. Exemplary methods for making these devices include skewering and molding the embolizing elements. In any of the embodiments, the embolizing elements may be made of a hydrophilic, macroporous, polymeric, hydrogel foam material. In the second, third and fourth embodiments, the elongate embolizing element is preferably made of a porous, environmentally-sensitive, expansile hydrogel, which can optionally be made biodegradable and/or bioresorbable, having a rate of expansion that changes in response to a change in an environmental parameter, such as the pH or temperature of the environment.

Claims

1-20. -20. (canceled)

21. A fallopian tube occlusion device comprising:

an elongated carrier; and

an expansile element encapsulating at least a portion of a length of the elongated carrier.

22. The fallopian tube occlusion device of claim 21 wherein the expansile element comprises a hydrophilic polymer.

23. The fallopian tube occlusion device of claim 21 wherein the expansile element is filamentous.

24. The fallopian tube occlusion device of claim 21 wherein the expansile element comprises a stretch-resistant layer applied over an external surface of the elongated carrier.

25. The fallopian tube occlusion device of claim 21 wherein the elongated carrier has an unconstrained secondary structure in the shape of a loop.

26. The fallopian tube occlusion device of claim 21 further comprising a linkage element reversibly coupling the device to a deployment instrument.

27. A tubal sterilization device comprising:

an elongated carrier having a secondary unconstrained looped structure; and

a plurality of hydrophilic expansile elements encapsulating the elongated carrier at spaced intervals along a length of the carrier.

28. The device of claim 27 wherein at least one of the plurality of hydrophilic expansile elements comprises a polymer having a controlled rate of expansion from a contracted state to an expanded state.

29. The device of claim 27 wherein the plurality of hydrophilic expansile elements occupy at least a portion of a lumen of the carrier.

30. The device of claim 27 wherein the elongated carrier comprises a microcoil.

31. The device of claim 27 further comprising a linkage element reversibly coupling the device to a deployment instrument.

32. A method for tubal sterilization comprising:

introducing a distal end of a deployment device proximate a target site;

passing a tubal sterilization device in a first state through a lumen of the deployment device so that the tubal sterilization device emerges from the distal end of the deployment device substantially into the target site,

transforming the tubal sterilization device from the first state to a second state that substantially occludes the target site; and

withdrawing the deployment device from proximate the target site such that the tubal sterilization device remains in the target site after withdrawal of the deployment device.

33. The method of claim 32 wherein the step of passing a tubal sterilization device in a first state through a lumen of the deployment device comprises passing the tubal sterilization device through a catheter.

34. The method of claim 32 wherein the step of transforming the tubal sterilization device from the first state to a second state comprises transforming an expansile element of the tubal sterilization device.

35. The method of claim 34 wherein the step of transforming an expansile element of the tubal sterilization device comprises expanding a hydrophilic polymer.

36. The method of claim 34 wherein the step of transforming an expansile element of the tubal sterilization device comprises expanding an pH sensitive polymer.

37. The method of claim 32 wherein the step of transforming an expansile element of the tubal sterilization device comprises hydrating a polymer.

38. A method for making a fallopian tube occlusion device, the method comprising:

providing an elongated carrier;

encapsulating at least a portion of a length of the carrier in an expansile hydrophilic element; and

dehydrating the expansile hydrophilic element.

39. The method of claim 38 wherein the step of encapsulating at least a portion of a length of the carrier comprises skewering the expansile hydrophilic element with the carrier.

40. The method of claim 38 wherein the step of encapsulating at least a portion of a length of the carrier comprises axially stretching the elongated carrier.